FDA.reportPublic FDA data

Povidone Iodine Impregnated

Manufacturer
Jianerkang Medical Co., Ltd
Effective date
2023-10-23
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-05-31 23:57:31

Label at a glance#

ProductPovidone Iodine Impregnated
Active ingredientPOVIDONE-IODINE
Label structure10 sections

Indications and uses

For preparation of skin and mucous membranes prior to surgery

Dosage and administration

open pouch at tear notch use sponge sticks to prep desired area

Storage and handling

store at room temperature avoid excessive heat (above 104 F/40 C) protect from freezing latex free o o

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Povidone Iodine, USP 7.5% (0.75% available Iodine)

Purpose

OTC - PURPOSE SECTION

Antiseptic

Uses

INDICATIONS & USAGE SECTION

For preparation of skin and mucous membranes prior to surgery

Warnings

WARNINGS SECTION

For external use only

Avoid use on persons allergic to iodine

Stop use and ask a doctor if

OTC - STOP USE SECTION

Skin shows symptoms of irritation, sensitivity, redness, pain or swelling

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact Poison Control Center right away

Directions

DOSAGE & ADMINISTRATION SECTION

open pouch at tear notch

use sponge sticks to prep desired area

Other information

STORAGE AND HANDLING SECTION

store at room temperature avoid excessive heat (above 104 F/40 C) protect from freezing latex free


o o

Inactive Ingredients

INACTIVE INGREDIENT SECTION

purified water, hydroxyethylcellulose, Nonylph

Package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

l3l3

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
5f30b278-5791-4113-8781-878a9221ef8aProduct name220230125
2a70c781-a755-4d76-b20a-a958acfbdcdcProduct name220190619
304592ef-4a8a-4c22-8e8c-af73aa3d60e5Product name120180703
ac0821a1-ce75-4ea7-880a-59eecaecdf22Product name120180703
db5dc4f9-b907-46f6-8fb7-babcf04bbe5cProduct name120180619
41e9d6cf-3ed7-4c44-a57e-0685058d0896Product name120170824
5e652c92-68fd-426b-b0e7-5fc64e0b9f99Product name120170309
ddc0c11a-bba8-408f-b3c7-c4828b4bcc8cProduct name120150421

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
34645-1032-1Povidone Iodine Impregnated10 in 1 BOXSPONGE104
34645-1032-1Povidone Iodine Impregnated100 mL in 1 POUCHSPONGE1004

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
34645-1032POVIDONE IODINE IMPREGNATED (POVIDONE IODINE) SPONGE [JIANERKANG MEDICAL CO., LTD]4Current NDC, Legacy NDC, 2 package rows20231024_deea0412-266d-46a5-a3ec-fa4400fcdc0a.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
POVIDONE-IODINEACTIVE INGREDIENT85H0HZU99M1
IODINEACTIVE MOIETY9679TC07X41
HYDROXYETHYL CELLULOSE (100 MPA.S AT 2%)INACTIVE INGREDIENTR33S7TK2EP1
WATERINACTIVE INGREDIENT059QF0KO0R1

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 6 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
34645-103234645-1032-1

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 3 matching rows.

Name, UNII, Kind table
NameUNIIKind
HYDROXYETHYL CELLULOSE (100 MPA.S AT 2%)R33S7TK2EPIACT
WATER059QF0KO0RIACT
POVIDONE-IODINE85H0HZU99MACTIM

Source Document#

Source XML · Source PDF

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 2 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
HYDROXYETHYL CELLULOSE (100 MPA.S AT 2%)HYDROXYETHYL CELLULOSE (100 MPA.S AT 2%)R33S7TK2EPSOLUTION / TOPICAL0.6 %w/vExact identifier — unii+route
2 equally ranked IID candidates
HYDROXYETHYL CELLULOSE (100 MPA.S AT 2%)HYDROXYETHYL CELLULOSE (100 MPA.S AT 2%)R33S7TK2EPSOLUTION / TOPICAL0.6 %w/vExact identifier — unii+route
2 equally ranked IID candidates

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Povidone Iodine ImpregnatedPOVIDONE IODINEJianerkang Medical Co., Ltddeea0412-266d-46a5-a3ec-fa4400fcdc0a2023-10-23WarningsExact identifier
ndc (package): 34645-1032-1
ndc (product): 34645-1032
ndc11 (package): 34645103201
spl id: 085eb07c-f4dd-b961-e063-6394a90a54ad
spl set id: deea0412-266d-46a5-a3ec-fa4400fcdc0a

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.